Auris Health, Inc: Device Recall

Recall Details

Recall Number

Z-0543-2026

Classification

Class II

Product Type

Device

Recalling Firm

Auris Health, Inc

Status

Ongoing

Date Initiated

10/18/2025

Location

Santa Clara, CA, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

1,477 units

Reason for Recall

Potential that product was leak tested with equipment outside of its expected operating range, resulting in bronchoscopes that may not be susceptible to leaks.

Product Description

MONARCH Bronchoscope. Model Number: MBR-000211-B

Distribution Pattern

Nationwide distribution to AL, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KY, MA, MI, MS, MT, NC, NE, NJ, NM, NY, OH, OR, PA, SC, SD, TN, VA, VT, WA, WV.

Other Recalls by Auris Health, Inc

• Class II: Risk 08/02/2024
  Endoscopy/bronchoscopy/urology devices may have a strain relief defect with some cart and tower power cords that may cause an electrical short, which may lead to system shutdown, which can lead to prolonged procedure or case conversion, and if the user (e.g., operating room staff) touches exposed wires or conductive fluids in contact with the exposed wires, there is a chance of electrical shock.
• Class II: Risk 08/02/2024
  Endoscopy/bronchoscopy/urology devices may have a strain relief defect with some cart and tower power cords that may cause an electrical short, which may lead to system shutdown, which can lead to prolonged procedure or case conversion, and if the user (e.g., operating room staff) touches exposed wires or conductive fluids in contact with the exposed wires, there is a chance of electrical shock.

View all recalls by Auris Health, Inc →